Ademetionine (S-Adenosylmethionine) Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of Ademetionine across diverse indications, prominently including hepatic and metabolic disorders—such as chronic hepatitis B with cholestasis, drug-induced liver injury, and nonalcoholic fatty liver disease—alongside major depressive disorder, esophageal squamous cell carcinoma, and muscle injury. Ranging from early Phase 1/2 evaluations to Phase 4 post-marketing studies and observational protocols, these investigations are supported by academic centers, hospital networks, and commercial sponsors. Recruitment statuses across these trials vary, encompassing active recruitment, completed studies, and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07367724	RECRUITING	Obstructive Hypertrophic Cardiomyopathy (oHCM)	China National Center for Cardiovascular Diseases	2026-01-01	PHASE2
NCT06922669	RECRUITING	Drug Induced Liver Injury	General Hospital of Shenyang Military Region	2025-06-24
NCT07068191	RECRUITING	Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Hepatomegaly; Nonalcoholic Fatty Liver (NAFL); Nonalcoholic Fatty Liver Disease (NAFLD); Fatty Liver; Fatty Liver, Alcoholic; Fatty Liver, Nonalcoholic; Fatty Liver Disease	Phenomen Pharma	2025-06-19
NCT05312372	Withdrawn	Esophageal Squamous Cell Carcinoma	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2025-05	Phase 1\|Phase 2
NCT05775718	Recruiting	Bone Marrow Transplant\|Stem Cell Transplant	University of Colorado Denver\|GlaxoSmithKline	2024-12-01	Phase 2
NCT05279196	Not yet recruiting	Muscle Injury	University Hospital Montpellier	2024-09	Not Applicable
NCT06309173	Not yet recruiting	Multiple Sclerosis	University Hospital Basel Switzerland	2024-09	--
NCT06251999	Not yet recruiting	Elderly Patients	Shanghai 6th People''s Hospital	2024-08-01	Phase 4
NCT06280742	Not yet recruiting	Multiple Sclerosis	Assistance Publique - Hôpitaux de Paris	2024-07-01	Not Applicable
NCT01998620	UNKNOWN	Hepatitis B; Cholestasis	Zhejiang Hisun Pharmaceutical Co. Ltd.	2013-11	PHASE4
NCT02200029	COMPLETED	Intrahepatic Cholestasis Associated With Alcoholic Liver Disease	Abbott	2014-06	PHASE3
NCT04623034	COMPLETED	Major Depressive Disorder	MSI Methylation Sciences, Inc.	2013-04-17	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the Ademetionine (S-Adenosylmethionine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ademetionine acts as a principal methyl donor in enzymatic transmethylation reactions, transferring its methyl group to biological molecules to regulate essential cellular transsulfuration and polyamine biosynthetic pathways. By enhancing intracellular glutathione synthesis and mitigating oxidative damage in hepatocytes, this biochemical activity supports tissue preservation and underpins its clinical investigation in liver disorders such as cholestasis, hepatitis, and fatty liver disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).